What is the Active Ingredient in Personalized Feedback Interventions for Problem Drinkers? A Randomized Controlled Trial
1 other identifier
interventional
804
1 country
1
Brief Summary
The major objective of this project is to conduct a randomized controlled trial comparing the impact of the normative feedback and other personalized feedback components of the Check Your Drinking (CYD) Internet-based intervention in the general population. Eligible problem drinking participants will be randomly assigned to one of four conditions in a 2 by 2 design - to receive just the normative feedback component of the CYD intervention, just the other personalized feedback information, to a no intervention control condition, or to receive the full CYD intervention. The no intervention control condition will not be sent any intervention materials but will instead be sent a list of the different components of the CYD feedback and will be asked to think about how useful they would find each of them. All participants will be followed-up at 3 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 28, 2012
CompletedFirst Posted
Study publicly available on registry
May 31, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedDecember 9, 2014
December 1, 2014
1.1 years
May 28, 2012
December 5, 2014
Conditions
Outcome Measures
Primary Outcomes (3)
Drinks in a typical week
Number of drinks in a typical week
3 months
AUDIT-C score
Composite measure of three drinking items - frequency of drinking, drinks per drinking day, frequency of 5+ drinking days
3 months
Highest number of drinks on one occasion
Highest number of drinks on one occasion in the past 3 months
3 months
Study Arms (4)
Full personalized feedback
EXPERIMENTALParticipant provided with the full CYD personalized feedback summary.
Only normative feedback
EXPERIMENTALParticipant provided with just the normative feedback component of the CYD personalized feedback summary.
Just other personalized feedback
EXPERIMENTALParticipant provided with all the other personalized feedback components of the CYD intervention (i.e., no normative feedback).
No intervention control
NO INTERVENTIONParticipant provided with a list describing the components of the CYD intervention but not provided any personalized feedback.
Interventions
The CYD provides problem drinkers with a personalized summary of their drinking that compares his or her drinking with that of the general population. The CYD also provides an assessment of the severity of the person's drinking problem.
Eligibility Criteria
You may qualify if:
- problem drinkers as measured by an AUDIT score of 8 or more
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre for Addiction and Mental Health
Toronto, Ontario, M5S 2S1, Canada
Related Publications (1)
Cunningham JA, Murphy M, Hendershot CS. Treatment dismantling pilot study to identify the active ingredients in personalized feedback interventions for hazardous alcohol use: randomized controlled trial. Addict Sci Clin Pract. 2014 Dec 10;10(1):1. doi: 10.1186/s13722-014-0022-1.
PMID: 25539597DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Cunningham, Ph.D.
Centre for Addiction and Mental Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 28, 2012
First Posted
May 31, 2012
Study Start
May 1, 2012
Primary Completion
June 1, 2013
Study Completion
September 1, 2013
Last Updated
December 9, 2014
Record last verified: 2014-12